Spinal Cord Injury Collaborative Care Study (SCI-Care)
Primary Purpose
Spinal Cord Injury
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Collaborative Care
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring Chronic Pain, Mood, Physical Activity
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- diagnosis of traumatic spinal cord injury by medical record review
- receives primary SCI care from a provider at the University of Washington or Harborview Medical Center's Rehabilitation Outpatient Clinic
- positive screening for pain related to SCI diagnosis and/or
- positive screening for low mood and/or
- negative screening for physical activity levels
- able to speak and understand English
Exclusion Criteria:
- psychiatric condition that would interfere with participation
- major surgery in the next 8 months
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Care
Intervention
Arm Description
No intervention, usual care
Collaborative care with Health Care Assistant
Outcomes
Primary Outcome Measures
Change in Quality of Life
Quality of Life is assessed via telephone interviews at baseline and 4 months.
Secondary Outcome Measures
Change in Pain
Pain is assessed via telephone interview at baseline, 4 months, and 8 months.
Change in Mood
Mood assessed via telephone interviews at baseline, 4 months, and 8 months.
Change in Physical Activity
Physical activity is assess via telephone interview at baseline, 4 months, and 8 months.
Change in Quality of Life
Change in QOL from baseline to 8 months will be compared between groups
Adverse events
The number of cases with serious or non-serious adverse events in the two arms
Full Information
NCT ID
NCT02026167
First Posted
December 26, 2013
Last Updated
February 23, 2019
Sponsor
University of Washington
Collaborators
U.S. Department of Education
1. Study Identification
Unique Protocol Identification Number
NCT02026167
Brief Title
Spinal Cord Injury Collaborative Care Study
Acronym
SCI-Care
Official Title
SCI-CARE (Northwest Regional Spinal Cord Injury Site Specific Project)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
U.S. Department of Education
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this study is to test the effectiveness of a collaborative care approach to improving outpatient treatment for inactivity, chronic pain and depression as a way of improving overall Quality of Life for patients with SCI.
Detailed Description
Individuals with SCI were treated by a care manager who worked in collaboration with the participant's physician to decrease pain, decrease depression symptoms, and/or to increase physical activity. This was done by collaborating on current treatments to make sure that they are being as effective as possible and by providing non-pharmacological treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
Chronic Pain, Mood, Physical Activity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
174 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
No intervention, usual care
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Collaborative care with Health Care Assistant
Intervention Type
Behavioral
Intervention Name(s)
Collaborative Care
Intervention Description
Addition of a Health Care Assistant to treatment team, case review by expert panel of supervisors, non-medical interventions
Primary Outcome Measure Information:
Title
Change in Quality of Life
Description
Quality of Life is assessed via telephone interviews at baseline and 4 months.
Time Frame
Baseline, 4 months
Secondary Outcome Measure Information:
Title
Change in Pain
Description
Pain is assessed via telephone interview at baseline, 4 months, and 8 months.
Time Frame
Baseline, 4 months, 8 months
Title
Change in Mood
Description
Mood assessed via telephone interviews at baseline, 4 months, and 8 months.
Time Frame
Baseline, 4 months, 8 months.
Title
Change in Physical Activity
Description
Physical activity is assess via telephone interview at baseline, 4 months, and 8 months.
Time Frame
Baseline, 4 months, 8 months
Title
Change in Quality of Life
Description
Change in QOL from baseline to 8 months will be compared between groups
Time Frame
Baseline, 8 months
Title
Adverse events
Description
The number of cases with serious or non-serious adverse events in the two arms
Time Frame
baseline to 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older
diagnosis of traumatic spinal cord injury by medical record review
receives primary SCI care from a provider at the University of Washington or Harborview Medical Center's Rehabilitation Outpatient Clinic
positive screening for pain related to SCI diagnosis and/or
positive screening for low mood and/or
negative screening for physical activity levels
able to speak and understand English
Exclusion Criteria:
psychiatric condition that would interfere with participation
major surgery in the next 8 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles H Bombardier, Ph.D.
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://sci.washington.edu/scicare/
Description
General study information on the Northwest Regional SCI System website
Learn more about this trial
Spinal Cord Injury Collaborative Care Study
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